Paranasal sinus fluid access implantation tools, assemblies, kits and methods

ABSTRACT

An implantation tool to implant a paranasal sinus fluid access implant device to fluidly connect the lacrimal apparatus in the orbit with a paranasal sinus has a securement mechanism reconfigurable from a securement configuration to secure the implant device to a mounting portion of a carrier member to a released configuration to release the implant device from the carrier member, and with a release mechanism disposed at least partially in an interior working space housed within the implantation tool. An implantation method with an approach through the palpebral fissure advances the implant device through a surgical route mostly under tension.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/561,095, entitled “PARANASAL SINUS FLUID ACCESS IMPLANTATION TOOLS,ASSEMBLIES, KITS AND METHODS” filed Sep. 20, 2017, the entire contentsof which are incorporated herein by reference.

BACKGROUND

Millions of people are treated each year for infections of the paranasalsinuses, or sinusitis, with many of those suffering from chronicsinusitis. Conventional surgical interventions directed to providingenhanced irrigation and drainage may provide moderate symptomaticimprovement but not a cure. Recent interventions have been proposed todirectly access the paranasal sinuses to permit medical procedures ordrug treatments to be performed more directly in the paranasal sinuses.Direct access to a paranasal sinus has been proposed from an approachthrough the nose and an ostium that provides a natural opening from thenasal cavity into a paranasal sinus. Such medical interventions todirectly access a paranasal sinus through the natural opening of theostium involve complex manipulations of access tools to and through therestricted space of the ostium.

Another more recent intervention is based on providing an artificialfluid communication path between the lacrimal apparatus and a paranasalsinus through a paranasal sinus access implant device implanted throughan artificially formed surgical path between the lacrimal apparatus inthe paranasal sinus to provide direct fluid communication access fromthe lacrimal apparatus to the paranasal sinus through an internalpassage of the implanted implant device. One surgical approach isthrough the palpebral fissure to form a surgical path between thelacrimal apparatus in the orbit and a paranasal sinus, often the ethmoidsinus. Examples of some paranasal sinus access implant devices andimplantation tools and procedures for implanting such implant devices toprovide a fluid communication between the lacrimal apparatus and aparanasal sinus are disclosed for example in International PatentApplication Publication Nos. WO 2012/048278 A2; WO 2013/154843 A1; WO2014/116980 A1; WO 2015/069433 A1; WO 2016/014996 A1; WO 2016/015002 A1;and WO 2017/132573 A1 published by the World Intellectual PropertyOrganization.

When implanted, such paranasal sinus access implant devices provideconvenient access to the paranasal sinus for administration of drugs orirrigation fluid directly to the paranasal sinus or performance ofmedical procedures in the paranasal sinus. However, for enhancedcompatibility and interaction with surgically-penetrated tissue, suchparanasal sinus access implant devices may be made of relatively softand flexible material, for example polymeric materials, such as medicalgrade silicone, having a Shore A hardness often in a range of about60-80. Advancing such flexible implant devices through a properly sizedsurgical route, and without additional inflammation of tissue in andadjacent to the surgical path, can be difficult. Such implant devicesmay include anchor protrusions configured to interact with issue exposedin the surgical path to help anchor the implanted implant device. Forenhanced fit through and retention in the surgical path, the outsidediameter of the implant device may be larger than the diameter of thesurgical cut made to form the surgical path, especially at locations ofthe anchor protrusions. Resistance to insertion through the surgicalpath when an implant device is advanced into and through the surgicalpath during an implantation procedure may result in accordion-likedeformation of the flexible implant device that further increasesresistance to advancement of the implant device and complicatingperformance of the implantation procedure and increasing potential foradditional inflammation of tissue that can lead to patient discomfortand longer heal times. Additionally, the wall of the sinus bone that ispenetrated by the surgical cut to access the paranasal sinus may be verythin and susceptible to fracture and breakage during the implantationprocedure. Such fracturing and breakage of the wall of the sinus bonemay be detrimental to good securement of the implanted device in theimplantation position through the surgical cut, and is also not desiredfor good surgical practice.

Although surgical implantation techniques for implantation of suchparanasal sinus access implant devices to fluidly connect the lacrimalapparatus in the orbit and a paranasal sinus have achieved a significantlevel of success in accessing and treating conditions of the paranasalsinuses, implantation tools and procedures still may suffer from one ormore of these problems, and there is a significant need for improvedimplantation tools and procedures to further address such problems.

SUMMARY

The inventors have inventively recognized that these problems may beaddressed at least in part for implantation of paranasal sinus accessimplant devices of the type summarized above implanted with a surgicalapproach through the palpebral fissure to provide an artificial fluidcommunication connection between the lacrimal apparatus in the orbit anda paranasal sinus by providing implantation tools and implantationprocedures that maintain the paranasal access implant device mostly intension as the implant device is advanced from the palpebral fissureapproach through the surgical path during implantation procedure. Statedanother way, when most of the length of the implant device that isadvanced through the surgical path is pulled through the surgical path(in tension) rather than being pushed through the surgical path (incompression), the implant device is allowed to stretch out rather thanbunch up in an accordion-like fashion during advancement into andthrough the surgical path, which eases advancement of the implant devicethrough the surgical path and tends to reduce potential for causingfracture or breakage of the sinus wall bone, other tissue inflammationand the difficulty for the medical professional to perform theimplantation procedure. A result may be both that the implantationprocedure is faster and easier for a medical professional to perform andwith reduced potential for surgical complications.

A first aspect of this disclosure provides an implantation tool toimplant a paranasal sinus fluid access implant device with an internalfluid communication passage through an artificial, surgical path betweena lacrimal apparatus in the orbit and a paranasal sinus in animplantation procedure to provide direct fluid communication accessthrough the internal passage from the lacrimal apparatus in the orbit tothe paranasal sinus. The implantation tool may include:

-   -   a carrier member configured to carry the implant device on a        mounting portion of the carrier member in a mounted orientation        to position the implant device in an implantation position        through the surgical path from an approach through the palpebral        fissure during the implantation procedure;    -   a securement mechanism to secure the implant device in the        implantation orientation on the carrier member to carry the        implant device to the implantation position during the        implantation procedure, the securement mechanism being        reconfigurable from a securement configuration to secure the        implant device to the mounting portion of the carrier member in        the implantation orientation to a released configuration to        release the implant device from securement to the carrier member        to permit withdrawal of the carrier member relative to the        implant device to leave the implant device implanted in the        implantation position during the implantation procedure;    -   a handle portion connected with the carrier member and        configured to remain outside of the surgical path during the        implantation procedure and being manipulable by a medical        practitioner to direct implantation of the implant device during        the implantation procedure;    -   internal working space housed within at least a portion of the        handle portion and at least a portion of the carrier member;    -   a release mechanism disposed at least in part in the internal        working space and manipulable to reconfigure the securement        mechanism from the securement configuration to the released        configuration.

A second aspect of this disclosure provides an implantation assembly forimplanting a paranasal sinus fluid access implant device through asurgical path between a lacrimal apparatus in the orbit and a paranasalsinus in an implantation procedure to provide direct fluid communicationaccess from the lacrimal apparatus in the orbit to the paranasal sinusthrough an internal passage of the implant device. The implantationassembly of this second aspect may include:

-   -   such a paranasal sinus access implant device: and    -   an implantation tool, wherein the implant device is mounted in a        mounting orientation on a mounting portion of a carrier member        of the implantation tool with a securement mechanism of the        implantation tool in a securement configuration, and which        securement mechanism is reconfigurable to a released        configuration to release the implant device from securement to        the mounting portion of the carrier member.        The implantation tool in the implantation assembly of this        second aspect may be according to the first aspect of this        disclosure.

A third aspect of this disclosure provides an implantation kit forimplanting a paranasal sinus fluid access implant device through asurgical path between a lacrimal apparatus in the orbit and a paranasalsinus in an implantation procedure to provide direct fluid communicationaccess from the lacrimal apparatus in the orbit to the paranasal sinusthrough an internal passage of the implant device. The implantation kitof this third aspect may include:

an implantation tool, wherein the implant device is mountable in amounting orientation on a mounting portion of a carrier member of theimplantation tool with a securement mechanism of the implantation toolin a securement configuration, and which securement mechanism isreconfigurable to a released configuration to release the implant devicefrom securement to the mounting portion of the carrier member; and

-   -   such a paranasal sinus access implant device;    -   wherein, the implantation tool and implant device are assembled        or assemblable into an implantation assembly with the implant        device mounted in the mounting orientation on the mounting        portion of the carrier member with the securement mechanism in        the securement configuration.

The implantation tool of the kit of this third aspect may be accordingto the first aspect of this disclosure. The implantation assembly of thekit of this third aspect may be according to the second aspect of thisdisclosure.

A fourth aspect of this disclosure provides a method for implanting aparanasal sinus access implant device to fluidly connect a lacrimalapparatus in the orbit with a paranasal sinus. The method of this fourthaspect may include:

-   -   with a surgical approach through the palpebral fissure,        surgically forming an artificial surgical path between a        location in a lacrimal apparatus in the orbit and a paranasal        sinus;    -   advancing an implantation assembly including such a paranasal        sinus access implant device from an approach through the        palpebral fissure until the implant device extends through the        surgical path in the implantation position, wherein the        implantation assembly includes the implant device mounted in a        mounting orientation on a mounting portion of a carrier member        of an implantation tool with a securement mechanism of the        implantation tool in a securement configuration, and which        securement mechanism is reconfigurable to a released        configuration to release the implant device from securement to        the mounting portion of the carrier member;    -   manipulating the release mechanism to reconfigure the securement        mechanism from the securement configuration to the released        configuration;    -   withdrawing the implantation tool from the surgical path,        leaving the implant device implanted through the surgical path        fluidly connecting the lacrimal apparatus in the orbit with the        paranasal sinus.        The implantation tool used in the method of this fourth aspect        may be according to the first aspect of this disclosure. The        implantation assembly used in the method of this fourth aspect        may be according to the second aspect of this disclosure. The        implant device and the implantation tool used in the        implantation assembly used in the method of this fourth aspect        may be provided in an implantation kit according to the third        aspect of this disclosure.

A fifth aspect of this disclosure provides a method for implanting aparanasal sinus fluid access implant device through an artificial,surgical path between a lacrimal apparatus in the orbit and a paranasalsinus to provide direct fluid communication access from the lacrimalapparatus in the orbit to the paranasal sinus through an internalpassage of the implant device. The method of this fifth aspect mayinclude:

-   -   with the implant device secured to an exterior of a carrier        member of an implantation tool with a distal end of the implant        device disposed toward a distal end of the implantation tool and        a proximal end of the implant device disposed toward a proximal        end of the implantation tool and with an implantation approach        from the lacrimal apparatus in the orbit, advancing the implant        device through the surgical path between the lacrimal apparatus        in an orbit and the paranasal sinus until the implant device is        in an implantation position with the distal end of the implant        device disposed in the paranasal sinus and the proximal end of        the implant device disposed in the lacrimal apparatus in the        orbit;    -   after the advancing, releasing the implant device from        securement to the exterior of the carrier member and withdrawing        the carrier member from the surgical path to leave the implant        device implanted in the implantation position fluidly connecting        the lacrimal apparatus in the orbit with the paranasal sinus        through the internal passage of the implant device; and    -   the implant device having a length from the proximal end to the        distal end of the implant device;    -   wherein during the advancing a length portion of the implant        device, which is smaller than the length of the implant device,        enters into and advances at least some distance through the        surgical path, and a majority of the length portion is in        tension while advancing through the surgical path.        The method of this fifth aspect may include performance of the        method of the fourth aspect of this disclosure. The implantation        tool used in the method of this fifth aspect may be according to        the first aspect. The implant device secured to an exterior of a        carrier member of an implantation tool in the method of this        fifth aspect may be provided in an implantation assembly        according to the second aspect of this disclosure. The implant        device and the implantation tool used in the method of this        fifth aspect may be provided in an implantation kit according to        the third aspect of this disclosure.

These and other aspects of this disclosure and features for usetherewith are further described below. A number of feature refinementsand additional features disclosed below are applicable to each of theaspects of this disclosure, including to an implantation tool,implantation assembly, implantation kit and an implantation method ofany such aspect. These feature refinements and additional features maybe used individually or in any combination in any or all of theseaspects. As such, each of the features that will be discussed below maybe, but are not required to be, used with any other feature orcombination of features of the same or any other aspect of thisdisclosure.

Numerous additional features and advantages of the present disclosurewill become apparent to those skilled in the art upon consideration ofthe embodiment descriptions provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration showing the lacrimal apparatus and someexample routes for surgical paths between the lacrimal apparatus in theorbit and a paranasal sinus with a surgical approach through thepalpebral fissure for implantation of an implant device to providedirect fluid communication access from the lacrimal apparatus in theorbit to the paranasal sinus.

FIG. 2 is a perspective view of an example embodiment of a paranasalsinus access implant device for implantation to provide direct fluidcommunication access from the lacrimal apparatus in the orbit to theparanasal sinus.

FIG. 3 is a side view of the paranasal sinus access implant deviceillustrated in FIG. 2.

FIG. 4 is an illustration showing an example embodiment of a paranasalsinus access implant device in an implantation position as implanted toprovide direct fluid communication access from the lacrimal apparatus inthe orbit to an ethmoid sinus.

FIG. 5 is a perspective view showing an implantation assembly includingan example embodiment of an implantation tool in an implantationassembly combination with an example paranasal sinus access implantdevice to be implanted using the implantation tool to provide directfluid communication access from the lacrimal apparatus in the orbit tothe paranasal sinus.

FIG. 6 is an exploded view showing components of the implantation toolof FIG. 5.

FIG. 7 is a sectional view taken along a section line along the lengthof the implantation tool of FIG. 5 in the implantation assemblyconfiguration of FIG. 5 including the example paranasal sinus accessimplant device of FIG. 5.

FIG. 8 is a side view of a first portion of a slidable member of theimplantation tool of FIG. 5.

FIG. 9 is a side view of a distal end portion of the first portion ofthe slidable member illustrated in FIG. 8.

FIG. 10 is a side view of the slidable member of the implantation toolof FIG. 5.

FIG. 11 is an end view of the slidable member shown in FIG. 10.

FIG. 12 is a perspective view of a distal end portion of the toolassembly combination shown in FIG. 5.

FIGS. 13-15 are perspective views illustrating use of the implantationtool shown in FIG. 5 during an implantation procedure to implant theexample embodiment of a paranasal sinus access implant device shown inFIG. 5.

FIGS. 16-18 are partial sectional views illustrating a distal endportion of the implantation tool and the example embodiment of aparanasal sinus access implant device shown in FIG. 5 during animplantation procedure.

FIG. 19 is a perspective view showing another example embodiment animplantation tool for use to implant a paranasal sinus access implantdevice to provide direct fluid communication access from the lacrimalapparatus in the orbit to the paranasal sinus.

FIG. 20 is an exploded view showing components of the implantation toolof FIG. 19.

FIG. 21 is a top view of the implantation tool of FIG. 19.

FIG. 22 is a sectional view of the implantation tool of FIG. 19 takenalong a longitudinal section line as shown in FIG. 21.

FIG. 23 is a partial sectional view of the implantation tool of FIG. 19taken along a transverse section line as shown in FIG. 21.

FIG. 24 is a partial side view of a distal end portion of a carriermember of the implantation tool of FIG. 19.

FIG. 25 is a perspective view of a distal end portion of theimplantation tool of FIG. 19.

FIGS. 26-28 are perspective views illustrating use of the implantationtool of FIG. 19 in for performing an implantation procedure.

DETAILED DESCRIPTION

The term “lacrimal apparatus” or “lacrimal system” refers to thecollection of physiological components that accomplish the productionand secretion of lacrimal fluid to lubricate the eyeball, containment oflacrimal fluid in a reservoir of lacrimal fluid in the orbit anddrainage of lacrimal fluid from the orbit to the nasal cavity. Thelacrimal apparatus includes the lacrimal glands, the tear drainagesystem and the reservoir of lacrimal fluid located between the lacrimalglands and the tear drainage system. The reservoir of lacrimal fluidincludes the eyelid margins and the conjunctival sac (and including thepool of tears in the lower conjunctival cul-de-sac that is sometimesreferred to as the lacrimal lake). The tear drainage system includes thepuncta, canaliculi and nasolacrimal duct (including the so-calledlacrimal sac located at the top of the nasolacrimal duct) through whichexcess tears drain to Hasner's valve and into the nasal cavity. FIG. 1shows generally the lacrimal apparatus. Lacrimal fluid is produced andsecreted from lacrimal glands 102 to lubricate the surface of theeyeball 104 disposed within the orbit. Lacrimal fluid forms a coatingover the eyeball 104 and is generally contained within the conjunctivalsac (the space between the lower eyelid 106, upper eyelid 108 andeyeball 104 that is lined by the conjunctiva). Excess lacrimal fluid isconducted to the vicinity of the medial canthus (medial corner of theeye) and drains through the lacrimal puncta 110 into the lacrimalcanaliculi 112 and into the lacrimal sac 114 of the nasolacrimal duct116. The lacrimal fluid then drains from the nasolacrimal duct 116through Hasner's valve and into the nasal cavity.

As used herein, a surgical path refers to an artificially-createdpassage prepared by surgical means from an approach through thepalpebral fissure between the lacrimal apparatus in the orbit and aparanasal sinus for implantation therethrough of an implant device withan internal passage to provide direct fluid communication access fromthe lacrimal apparatus in the orbit to the paranasal sinus. As may beappreciated, the palpebral fissure is an anatomical opening betweeneyelids, also referred to as the rima palpebrarum. Such an implantdevice may, for example, be of a design as described in any of U.S. Pat.Nos. 9,308,358; 9,561,350; U.S. Patent Application Publication No.2017/0216094 A1 or International Patent Application Publication No. WO2017/132573 A1, each of which is incorporated by reference herein.

The paranasal sinuses include the frontal sinuses, maxillary sinuses,ethmoid sinuses and sphenoid sinuses, which are cavities containedwithin frontal, maxilla, ethmoid and sphenoid bones, respectively. Theparanasal sinuses drain into the nasal cavity. FIG. 1 also shows thegeneral proximity of the frontal sinus 122, maxillary sinus 124 andethmoid sinus 126 relative to features of the lacrimal apparatus andsome example routes for a surgical path are shown by dashed lines. Afirst example route 130 for a surgical path is from the lacrimalapparatus in the orbit to the frontal sinus. A second example surgicalpath route 132 is from the lacrimal apparatus in the orbit to theethmoid sinus 126. A third example surgical path route 134 is from thelacrimal apparatus in the orbit to the maxillary sinus 124. The examplesurgical path routes shown in FIG. 1 are for purposes of generalillustration only and not to show precise locations where a surgicalpath might be formed to connect a part of the lacrimal apparatus withthe corresponding paranasal sinus. Although not shown in FIG. 1, anotherexample route for a surgical path is from the lacrimal apparatus in theorbit to the sphenoid sinus. One more specific example of a preferredroute for a surgical path to a paranasal sinus is for the surgical pathto pass directly through the lacrimal caruncle and through tissue to thetargeted paranasal sinus. Such a route for a surgical path benefits fromrelatively easy location of the surgical entry point by a medicalprofessional performing an implantation procedure.

FIGS. 2 and 3 show an example implant device 200 of a design asdescribed in International Patent Application Publication No. WO2017/132573 A1. The implant device 200 includes a head 202 and a conduit204. The conduit 204 includes a first longitudinal portion 206 and asecond longitudinal portion 208 disposed distal of the firstlongitudinal portion 206. The first longitudinal portion 206 includes asmooth exterior surface and second longitudinal portion 208 includes ananchoring surface feature including anchoring protrusions in the form ofspaced circumferential ridges 210 and recess areas 212 between theridges 210. When the implant device 200 is implanted through a surgicalpath to fluidly connect the lacrimal apparatus in the orbit with aparanasal sinus, one or more of the ridges 210 may be located in thevicinity of the paranasal sinus bone wall that is penetrated by theimplant device 200 when implanted, preferably with one or more of theanchor protrusions disposed on each side of the bone, and morepreferably with the wall of the sinus cavity bone penetrated by theimplant device 200 disposed between two adjacent ones of the ridges 210.The implant device 200 includes an internal passage 238 extendingbetween the proximal end 216 and the distal end 218, passing through thehead 202 and the full length of the conduit 204. The internal passage238 is open at the proximal end 216 for fluid communication with thelacrimal apparatus in the orbit when implanted and is open at the distalend 218 for fluid communication with a paranasal sinus when implanted,whereby the implant device 200 when implanted provides a fluidcommunication path between the lacrimal apparatus in the orbit and theparanasal sinus. Disposed between the most distal pair of adjacentridges 210, the implant device 200 includes two side ports 250 disposedon opposite sides of a longitudinal axis 251 of the implant device 200,and which side ports are designed to be disposed in the paranasal sinuswhen the implant device 200 is implanted.

Various dimensions are shown in FIG. 3 for the implant device 200. Theimplant device 200 includes a length 214 measured longitudinally betweenthe proximal end 216 and the distal end. The circumferential ridges 210have a width 222 at the base of the ridges 210 and a height 224 aboveadjacent recess areas 212. The ridges 210 are spaced on acenter-to-center spacing 226, with inter-ridge spacing 227 betweenadjacent bases of adjacent ridges 210. The conduit 204 has a maximumexterior width 228 corresponding with the tops of the ridges 210, equalto the diameter of the circle of the cross-section through the conduit204 at the top of the ridges 210. The conduit 204 has a minimum exteriorwidth 231 at locations corresponding with the recess areas 212 on thesecond longitudinal portion 208 of the conduit 204. The head 202 has acircular perimeter having a diameter 234 and a depth 236. The beginning,or proximal end, of the second longitudinal portion 208 is located at adistance 220 from the proximal end 216, at the base of the ridge 210nearest to the proximal end 216 and the second longitudinal portion 208has a length 221. The internal passage 238 has a circular cross-sectionalong the length of the implant device 200, which is of constantdiameter except that the diameter of the internal passage flares to alarger diameter in transition portions adjacent the proximal end 216 andthe distal end 218, which are further described below.

Some example values for a number of the dimensions shown in FIG. 3 forone example embodiment of the implant device 200 are summarized in Table1.

TABLE 1 Dimension of Implant Device 200 Specific Example 214 17.8 mm 2208 mm 221 8.9 mm 222 0.44 mm 224 0.3 mm 226 1.65 mm 227 1.21 mm 228 2.41mm 230 2 mm 231 1.8 mm 234 4 mm 236 0.9 mm

Further features of the example implant device 200 are described inInternational Patent Application Publication No. WO 2017/132573 A1.

FIG. 4 shows an example of implant placement of the implant device 200in an implantation position to fluid connect the lacrimal apparatus inthe orbit with the ethmoid sinus. In the implantation position shown inFIG. 4, the head 202 and proximal end 216 are disposed in the lacrimalapparatus in the orbit in the conjunctival sac and the distal end 218 isdisposed in the ethmoid sinus 126, with the conduit 204 passing throughthe surgical path across tissue including conjunctiva and a wall of theethmoid bone in which the ethmoid sinus 126 is located, with some anchorridges 210 disposed within the surgical path to engage tissue and helpanchor the implant device 200, and with other ones of the anchor ridges210 and the side ports 250 disposed in the ethmoid sinus. In analternative example, the surgical path from the lacrimal apparatus inthe orbit may pass directly through the lacrimal caruncle 142, and inthe implantation position the head 202 may be disposed over and engagetissue of the lacrimal caruncle 142.

Whether the implanted implant design has a design of a type asillustrated in FIGS. 2 and 3 or a different design, after implantation,the implant device may be used to provide access to the paranasal sinusto perform medical procedures or treatments directed to the paranasalsinus, for example to administer a treatment composition (also referredto as a treatment formulation) the paranasal sinus or to aspirate fluidfrom the paranasal sinus. Such a treatment formulation may include oneor more drugs for treatment of sinusitis or may be an irrigation fluidto irrigate the paranasal sinus.

With reference also to FIGS. 5-18, an embodiment of a paranasal sinusfluid access implantation tool 300 and various components of and exampleimplantation procedures involving the implantation tool 300 will bedescribed. For illustration purposes, the implantation tool 300 is shownin an implantation assembly with or being operated in connection withimplantation of the example paranasal sinus fluid access implant device200 shown in FIGS. 2-4.

The implantation tool 300 includes an insertion portion 302 configuredto carry the implant device 200 for insertion through a surgical pathbetween the lacrimal apparatus in the orbit and a paranasal sinus duringan implantation procedure. The implantation tool 300 also includes ahandle portion 304 configured to remain outside of the surgical pathduring the implantation procedure and which is manipulable by a medicalpractitioner to direct implantation of the implant device 200 during theimplantation procedure. The insertion portion 302 includes a carriermember 306 on which the implant device 200 may be mounted to be carriedto an implantation position through the surgical path from an approachthrough the palpebral fissure during an implantation procedure. Thecarrier member 306 includes a mounting portion 308. The mounting portion308 is a longitudinal portion of the carrier member 306 on which theimplant device 200 is secured to be carried by the carrier member 306during an implantation procedure. As illustrated in FIGS. 5 and 7, themounting portion 308 of the carrier member 306 corresponds with thelength of the carrier member 306 along which the implant device 200 issecured to be carried by the implantation tool 300 during animplantation procedure. In this regard, a distal end of the mountingportion 308 may correspond with the distal end 218 of the implant device200 and the proximal end of the mounting portion 308 may correspond withthe proximal end 216 of the implant device 200 as the implant device 200is secured to the carrier member 306 for an implantation procedure. Itis noted that although the implant device 200 is mounted on and securedto such a mounting portion 308 of the carrier member 306 in preparationfor an implantation procedure, when the implant device 200 is insertedon the carrier member 306 into the surgical passage during animplantation procedure, the implant device 200 may deform or shiftsomewhat relative to the carrier member 306, which may include amovement of some portion or portions of the implant device 200 along thecarrier member 306 outside of the mounting portion 308, on which theimplant device 200 was initially confined as initially mounted. Forinstance, with the implantation tool 300, only a distal portion theimplant device 200 is secured to the carrier member 306, so thatportions of the implant device 200 located proximal to the locations ofsecurement will be in tension as the implant device 200 is inserted intoand advanced through the surgical path for implant placement. Thisadvantageously permits the implant device 200 to stretch out andelongate along the carrier member 306 proximal of the securementlocations, and proximal portions of the stretched implant device 200 mayextend proximal of the mounting portion 308 of the carrier member 306.Likewise, the secured distal portion of the implant device 200 maydeform and shift position slightly around the locations of securement,which may slightly shift the positioning of the distal end 218 of theimplant device 200 relative to the distal end of the mounting portion308 of the carrier member 306.

As shown in FIGS. 5-17, a slidable member 310 is disposed mostly ininternal working space housed within the handle portion 304 and thecarrier member 306. The slidable member 310 is slidable along atranslation path within the internal working space, and a spring 312 mayprovide a force to propel the slidable member 310 to release the implantdevice 200 from securement to the carrier member 306 to deploy theimplant device 200 for implantation after the implant device 200 hasbeen advanced in a surgical path to an implantation position. As shownin the figures, the slidable member 310 includes a first portion 314 inthe form of an elongated conduit (e.g., hypodermic tube, also referredto as a hypo tube). The slidable member also includes a second portion316 to interact with the spring 312 and has a depressable member 318that may be depressed by a medical professional during an implantationprocedure to release the spring 312 from a charged state (pre-compressedstate) to propel the slidable member 310 toward a proximal end 320 ofthe implantation tool 300 to retract the slidable member 310 within theinternal working space to release the implant device 200 from securementto the carrier member 306 for implantation deployment. The depressablemember 318 interfaces with an actuation member in the form of anactuation button 322, which may be pushed by a medical professional todepress the depressable member 318 to actuate release of the implantdevice 200 from securement to the carrier member 306 during animplantation procedure. By way of example, the first portion 314 of theslidable member 310 may be in the form of a small diameter hypo tube(e.g., of stainless steel) and the second portion 316 of the slidablemember 310 may be a plastic structure (e.g., of polypropylene) moldedover the hypo tube.

FIG. 8 illustrates the first portion 314 of the slidable member 310 inthe form of a hypo tube with a flared proximal end 324 for more secureengagement with the over-molded second portion 316 of the slidablemember 310, as illustrated in FIGS. 10 and 11. The second portion 316 ofthe slidable member 310 includes retaining projections 326 to engage andretain the spring 312 relative to the slidable member 310. In theexample of the implantation tool 300, the actuation button 322 is partof a molded handle body piece (e.g., of polypropylene). In a compressedstate, a distal end of the spring 312 is disposed against a shoulderfeature 328 in the handle body. The implantation tool 300 includes alumen provided through the first portion 314 of the slidable member 310for passage of a guide wire therethrough to guide a distal end of theimplantation tool 300 to the surgical path during an implantationprocedure. The lumen is accessible from the proximal end 320 of theimplantation tool 300 through an opening 330 though an end-cap insert332 with tab portions 331 that lock into a proximal portion of anopening feature 333 in the handle body. The end-cap insert 332 enclosesthe internal working space adjacent the proximal end 320 and acts as astop for movement of the slidable member 310 when propelled toward theproximal end 320 when the spring 312 in a compressed state is releasedby depression of the depressable member 318 through manipulation of theactuation button 322.

A key feature of the implantation tool 300 is a securement mechanismprovided to secure the implant device 200 in an implantation orientationon the carrier member 306 to carry the implant device 200 to animplantation position through the surgical path during an implantationprocedure. The securement mechanism is reconfigurable from a securementconfiguration to secure the implant device 200 to the carrier member 306to a released configuration to release the implant device 200 fromsecurement to the carrier member 306 after being advanced through asurgical path to an implantation position, permitting withdrawal of theimplantation tool 300, and the carrier member 306, to disengage thecarrier member 306 from the positioned implant device 200 to leave theimplant device 200 in place for implantation. In the embodimentillustrated for the implant tool 300, the securement mechanism includestwo securement members in the form of sheath members 340 that areintegral with and provided as extensions at a distal end of the carriermember 306. In one example contemplated implementation, the carriermember 306 may be made of a polymeric composition with materialproperties permitting the integral sheath members 340 to be sufficientlyductile to be routed through the distally-located side ports 250 of theimplant device 200 from inside of to outside of the side ports 250 andthen distally over distal portions of the exterior of the implant device200 to engage and be retained in a secured configuration by retainmentstructure features provided on distal end portions of the slidablemembers 310. As seen in FIGS. 8, 9 and 12, a distal end portion of theslidable member 310 includes securement tabs 342 cut into the wall ofopposing sides of the distal end portion of the first portion 314 of theslidable member 310. Each of the securement tabs 342 is defined by aslot 344 cut through the wall of the first portion 314 of the slidablemember 310 so that each securement tab 342 is configured be receivedthrough a corresponding opening 346 through a corresponding distal endportion of a sheath member 340 for securement of a sheath members 340 tothe distal end portion of the slidable member 310. This permits thedistal end portion of each sheath member 340 to be hooked over acorresponding securement tab 342 with the securement tab 342 projectingthrough the opening 346 of the sheath member 340 to hold the sheathmember 340 secured in place in a securement configuration foradvancement of the implant device 200 mounted on the carrier member 306into and through a surgical route during an implantation procedure. Anexample of the engagement between the sheath members 340 andcorresponding ones of the securement tabs 342 projecting through theopenings 346 in an implantation assembly reading for an implantationprocedure is illustrated for example, in FIG. 16. The secured sheathmembers 340 in the securement configuration engaged with the securementtabs 342 both secure the implant device 200 in an implantationorientation mounted on the carrier member 306 and provide a sheath-likeprotection of distal end portions of the implant device 200 that arecovered by the sheath members 340, facilitating insertion of the implantdevice 200 into a surgical path and advancing the implant device 200through the surgical path to an implantation position with reducedresistance to advancement from the distal end edge of the implant device200. Securement of the implant device 200 to the carrier member 306 onlyat locations at and distal to the side ports 250 results in a majorityof the length of the implant device 200 located proximal to the sideports 250 that is advanced into and through the surgical path to beadvanced in a state of tension as a result of resistance to advancementfrom tissue in the surgical path pulling on the exterior of the conduit204 of the implant device 200 when the implant device 200 is advancedthrough the surgical path, until the head 202 of the implant device 200engages conjunctival tissue adjacent to the proximal opening of thesurgical path when the implant device 200 has been fully advanced to animplantation position. As shown in FIG. 16, the mounting portion 308 ofthe carrier member 306 extends to the distal end of the implant device200, with a distal end portion of the carrier member 306 extending alongan exterior of the implant device 200 to the distal end of the implantdevice 200. In the embodiment of the implantation tool 300, thesecurement members in the form of the sheath members 340 are integralportions of the carrier member 306, which together with the distal endportion of the slidable member 310 including the tab portions 342 arepart of a securement mechanism to secure the implant device in theimplantation orientation on the carrier member 306. Is should beappreciated that the term “carrier member” as used herein refers to acarrying structure, which may be a combination of pieces or parts thatduring an implantation procedure provide the carrying function with theimplant device mounted in a supported manner for advancing the implantdevice to an implantation position relative to a surgical path during animplantation procedure. In some alternative configurations to theimplantation tool 300 as illustrated in FIGS. 5-18, one or more sheathmembers may extend out of the end of the internal passage of an implantdevice and fold back over the distal end of the implant device to extendover an exterior of a distal end portion of the implant device. Forexample, such a folded-over sheath member may be retained along a distalend portion of the implant device 200 by a snare-type structure, forexample similar to as described below with respect to FIGS. 19-28, or byretainment features on a slidable member disposed in the vicinity of theside ports 250 of the implant device 200. In other alternativeconfigurations, sheath members may be separate from a carrier member,and not an integral part of a carrier member.

The implantation tool 300 includes a safety cover 350 attached to thehandle body to cover the actuation button 322 to prevent hand access tothe actuation button 322 to prevent premature release of the implantdevice 200 from securement to the carrier member 306 during animplantation procedure. When the implant device 200 has been positionedthrough a surgical path in an implantation position and ready to bereleased from securement to the carrier member 306 for implantation, thesafety cover 350 may be selectively removed from the handle body bypulling up on the safety cover 350, thereby permitting hand access tothe actuation button 322 to permit a medical practitioner to press theactuation button 322 to depress the depressable member 318 and todisengage a proximal projection 352 on the depressable member 318 from acorresponding recess feature in the handle body, as seen best in FIG. 7.As shown in FIG. 7, when the projection 352 is received in thecorresponding recess feature in the handle body, the depressable member318 is in a locked configuration maintaining the spring 312 in acompressed state. When the actuation button 322 is pushed down afterremoval from of the safety cover 350, the projection 352 is moved out ofthe locked configuration to permit expansion of the spring 312 from thecompressed state to propel the slidable member 310 toward the proximalend 320 of the implantation tool 300, resulting in disengagement of thesecurement tabs 342 from the sheath members 340 to release the sheathmembers 340 from securing the implant device 200 to the carrier member306. As the slidable member 310 moves toward the proximal end 300, adistal portion of the slidable member 310 is retracted into the interiorworking space within the carrier member 306, for example as illustratedin FIG. 17.

With continued reference primarily to FIGS. 5-18, performance of anexample implantation procedure will be described using the implantationtool 300. FIG. 13 illustrates an implantation assembly ready forperforming an implantation procedure with the implant device 200 mountedin an implantation orientation and secured to the carrier member 306.FIG. 16 illustrates a distal portion of the implantation tool 300 withthe implant device 200 secured to the carrier member 306 by the sheathmembers 340 engaged with the securement tabs 342 on the first portion314 of the slidable member 310, with the securement tabs 342 receivedthrough the openings 346 and the corresponding sheath members 340. Asillustrated in FIG. 16, the securement tabs 342 may be slightly flaredoutward to enhance performance of the securement tabs 342 both forsecuring the sheath members 344 insertion into the surgical path and forrelease of the sheath members 340 when the tool member slidable member310 is retracted to disengage from the sheath members 340 and to releasethe implant device 200 from securement to the carrier member 306. FIG.14 illustrates actuation of the implantation tool 300 to reconfigure thesecurement mechanism from the securement configuration to the releasedconfiguration during an implantation procedure after the implant device200 has been advanced into a surgical path to an implantation positionwith the distal end 218 disposed in a paranasal sinus (e.g., ethmoidsinus, maxillary sinus or frontal sinus) and with the proximal end 216disposed in the lacrimal apparatus in the orbit, and preferably with adistal side of the head 202 in contact with conjunctival tissue in theorbit. Such an implantation position for the implant device 200 may beas illustrated for example in FIG. 4, but with the implant device 200still secured to the carrier member 306 of the implantation tool 300. Asshown in FIG. 14, with the implant device 200 in the implantationposition through the surgical path, the safety cover 350 may be removedto permit access to the actuation button 322, which may be pushed toreconfigure the securement mechanism of the implantation tool 300 to thereleased configuration in which the implant device 200 is released fromsecurement to the carrier member 306, as illustrated in FIG. 17. Afterthe actuation button 322 has been pressed to release the implant device200 from securement to the carrier member 306, a medical professionalperforming an implantation procedure may pull back on the handle portion304 to withdraw the carrier member 306 from the surgical path to leavethe implant device 200 in place implanted in the implantation positionto fluidly connect a paranasal sinus with the lacrimal apparatus in theorbit, as shown in FIG. 15. As the carrier member 306 is being withdrawnrelative to the implant device 200, the distal portions of the sheathmembers 340 are retracted through the side ports 250 of the implantdevice 200 leaving the implant device 200 implanted in the implantationposition completely disengaged from the implantation tool 300, as shownin FIGS. 15 and 18, which may be in the implantation position asillustrated in FIG. 4.

The carrier member 306 of the implantation tool 300 may be made of auniform material of construction throughout, or may be made of a firstmaterial of construction (e.g., metallic or hard engineering plasticmaterial) with higher rigidity to carry the implant device 200 and asecond material of construction for the sheath members 340 with a lowerrigidity that is sufficiently malleable to be readily deformed to bepassed through the side ports 250 and to engage with the securement tabs342. Because of the support provided to the carrier member 306 by theslidable member 310 (e.g., made of stainless steel or another hard,rigid material) disposed through the carrier member 306, the entirecarrier member 306, including the integral sheath members 340, may bemade of a uniform material with properties advantageously selected forperformance of both the sheath members 342 and other portions of thecarrier member 306 to carry the implant device during an implantationprocedure. Some example materials that may be used as a single materialof construction for the carrier member 306, including the integralsheath members 342, or that may be used for only the sheath members 340,include polyimide, polyamide (e.g., nylon), Mylar, PET (polyethyleneterephthalate), FEP (fluorinated ethylene propylene), PTFE(polytetrafluoroethylene), nitinol suture, PVF (polyvinyl fluoride),composite polymer and silicone composite compositions. Some preferredcompositions are polymeric compositions, such as polyimide, polyamide(e.g., nylon), Mylar, PET (polyethylene terephthalate), FEP (fluorinatedethylene propylene) and PTFE (polytetrafluoroethylene) compositions,with polyamide (e.g., nylon) compositions more preferred for someimplementations. One example for particularly preferred materials ofconstruction for the carrier member 306, including the integral sheathmembers 342, are thermoplastic elastomers, and preferably polyetherblock amide elastomers (PEBAs). Polymeric compositions, or polymericmatrix for composites with a polymeric matrix, for the carrier member,and preferably for PEBA materials, with or without integral sheathmembers, may in some implementations have a Shore D hardness in a rangeof 50 to 100, preferably 60-90 and more preferably 60-80. One usefulgroup of such PEBA materials are the Pebax® compositions from Arkema,and preferably some of the harder Pebax® materials (e.g., with a Shore Dhardness of 60 or larger). For example some Pebax® compositions have aShore D hardness of around 72 and are especially useful. Another usefulgroup of such thermoplastic elastomers are the Vestamid® E compositionsfrom Evonik, and preferably some of the harder such materials (e.g.,having a Shore D hardness of 60 or larger).

With reference also to FIGS. 19-28, another embodiment of a paranasalsinus fluid access implantation tool 400 and various components of anexample implantation procedures involving the implantation tool 400 willbe described. For illustration purposes, the implantation tool 400 isdescribed for mounting and implanting the example paranasal sinus fluidaccess implant device 200 shown in FIGS. 2-4.

The implantation tool 400 includes an insertion portion 402 configuredto carry the implant device 200 for insertion through a surgical pathbetween the lacrimal apparatus in the orbit and a paranasal sinus duringan implantation procedure. The implantation tool 400 also includes ahandle portion 404 configured to remain outside of the surgical pathduring the implantation procedure in which is manipulable by a medicalpractitioner to direct implantation of the implant device 200 during theimplantation procedure. The insertion portion 402 includes a carriermember 406 on which the implant device 200 may be mounted to be carriedto an implantation position through the surgical path with an approachthrough the palpebral fissure during an implantation procedure. Thecarrier member 406 includes a mounting portion 408, which is alongitudinal portion of the carrier member 406 on which the implantdevice 200 is secured to be carried by the carrier member 406 during animplantation procedure. The mounting portion 408 generally correspondswith the length of the carrier member 406 along which the implant device200 is secured to be carried by the implantation tool 400 during animplantation procedure. A distal end of the mounting portion 408 maycorrespond with the distal end 218 of the mounted implant device 200 andthe proximal end of the mounting portion 408 may correspond with theproximal end 216 of the mounted implant device 200. Similar to thediscussion above concerning the implantation tool 300, although theimplant device 200 is mounted on and secured to such a mounting portion408 of the carrier member 406 in preparation for an implantationprocedure, when the implant device 200 is inserted on the carrier member406 into a surgical passage during an implantation procedure, theimplant device 200 may deform or shift somewhat relative to the carriermember 406, including possibly moving somewhat outside of the mountingportion 408 on which the implant device 200 was initially confined asinitially mounted.

A handle body of the handle portion 404 and the carrier member 406provide a housing for internal components disposed in internal spacewithin the implantation tool 400. A slidable release member 410 isdisposed in the internal working space within the handle portion 404 andthe carrier member 406. The release member 410 is slidable along atranslation path within the internal working space. The release member410 is connected with a release pin 412 that is engaged with and retainsa release spring 414. A proximal end of the release pin 412 is threadedinto an end piece 416 located adjacent a proximal end 417 of theimplantation tool. The end piece 416 is selectively manipulable by amedical professional during an implantation procedure to reconfigure asecurement mechanism of the implantation tool 400 from a securementconfiguration to a released configuration to release the implant device200 from securement to the carrier member 408 to permit the implantationtool 400 and the carrier member 406 to be withdrawn and disengaged fromthe implant device 200 to leave the implant device 200 implanted in animplantation position.

The implantation tool 400 includes a securement member in the form of asnare member 418 and an alignment member 420 to assist in properlypositioning and aligning the implant device 200 adjacent to the mountingportion 408 of the mounting member 406 with a distal end portion of theimplant device 200 disposed through a snare loop formed by the snaremember 418 for securing the implant device 200 to the carrier member 406in the secured configuration. The snare member 418 is configured to beretractable to retract the snare loop about a distal portion of theimplant device 200 disposed along the mounting portion 408 of thecarrier member 406 to secure the implant device 200 to the carriermember 406. The implantation tool 400 also includes a guide loop member422 that provides a small diameter loop near a distal end 424 of theimplantation tool 400 for receiving a guide wire therethrough to guidethe distal and 424 of the implantation tool 400 to a surgical pathduring an implantation procedure. The interior working space of thecarrier member 406 is enclosed at a distal end of the carrier member 406by a spherical end piece 426. The carrier member 406 may, for example,be in the form of a metallic hypo tube (e.g., stainless steel hypo tube)with a small diameter metallic ball (e.g., stainless steel bearing ball)for the spherical end piece 426 attached to and enclosing a distal endof the hypo tube.

The carrier member 406 includes five side apertures disposed toward thedistal end 424. Two apertures 428 on opposing sides of the carriermember 406 provide passages for the guide loop member to exit from theinterior working space of the carrier member 406. From the apertures 428the guide loop member 422 may extend in a proximal direction through theinterior working space of the carrier member 406 and may be connected tothe handle transition piece 436 at a distal end of the handle portion404 to retain the guide member loop 422 in a fixed orientation with adesired small diameter loop open to receive a guide wire for guiding thecarrier member 406 to a proximal end of the surgical path during animplantation procedure. An aperture 430 provides a passage for thealignment member to exit the interior working space of the carriermember 406. From the aperture 430, the alignment member 420 may extendin a proximal direction through the interior working space of thecarrier member 406 and may be connected to a slidable loading member 438disposed in the interior working space within the handle portion 404.Apertures 432 and 434 provide passages for the snare member to exit theinterior working space of the carrier member 406. From the aperture 432,a first portion of the snare member 418 may extend in a proximaldirection through the interior working space of the carrier member 406and may be connected with the loading member 438. A second portion ofthe snare member 418 may be disposed in the interior working space ofthe carrier member 406 with an engagement portion of the snare member418 in the form of an end loop 440 retained in the interior workingspace by a distal end portion of the release member 410 disposed throughthe end loop 440 when the snare member 418 is in the securementconfiguration to secure the implant device 200 to an exterior of thecarrier member 406. The release member 410 disposed through the loop end440 maintains the loop member 418 with a snare loop adjacent an exteriorof the carrier member 406 extending between the aperture 432 and theaperture 434. However, in the released configuration, the release member410 is retracted to disengage from the loop end 440 of the loop member418 to release the snare loop and accordingly to release the implantdevice 200 from securement to the carrier member 406.

The snare member 418 may be disposed in three different configurations,referred to as a loading configuration, a securement configuration and areleased configuration, respectively. In the loading configuration andthe released configuration, the release pin 410 is disposed through theloop end 440 of the snare member 418 to maintain the snare member 418with a snare loop extending between the aperture 432 and the aperture434. In the loading configuration, the loading member 438 is in aforward position, as illustrated in FIGS. 22 and 23, and accordingly theend of the snare loop 418 connected to the loading member 438 is also ina forward position and the snare loop is in an expanded position toreceive the implant device 200 to be secured to the mounting portion 408of the carrier member 406. With the snare member 418 in the loadingconfiguration, the implant device 200 may be guided to the properposition for securement to the carrier member 406 by inserting thealignment member 420 into the internal passage from the distal end 218of the implant device 200 and sliding the implant device 200 over thealignment member 420 until the distal end 218 of the implant device 200is stopped adjacent the aperture 434 by a bend portion of the alignmentmember 420 where the alignment member 420 exits the aperture 430. Asfully advanced along the alignment member 420, a distal end portion ofthe implant device 200 will be disposed through and distal of the snareloop of the snare member 418. With the implant device 200 in such aposition fully advanced along the alignment member 420, the snare member418 may be repositioned to the securement configuration by a medicalprofessional by retracting the loading member 438 along a translationpath in the interior working space of the handle portion, resulting inretraction of the end of the snare member 418 connected to the loadingmember 438 to retract the snare loop of the snare member 418 to aretracted position around the distal end portion of the implant device200 disposed through the snare loop 418. In the retracted position, thesnare loop closes around the exterior of the implant device 200 andcollapses the internal passage through the implant device 200 at theretracted snare loop location to firmly secure the implant device 200 tothe mounting portion 408 of the carrier member 406. In contrast to theexample implantation tool 300 in which the implant device 200 has thecarrier member 306 disposed through the internal passage of the implantdevice 200 when the implant device 200 is secured to the carrier member306, in the example implementation tool 400, the mounted implant device200 is in the absence of the carrier member 406 disposed through theinternal passage of the implant device 200 secured to the carrier member406.

To reconfigure the snare member 418 from the loading configuration tothe securement configuration, a medical professional may pull back on anactuation projection in the form of a knob member 446 connected with theloading member 438 with a portion of the knob member 446 disposedthrough and guided by a longitudinal portion of a slot track formed in awall of a handle body providing a housing for components in the interiorworking space of the handle portion 404. As the knob member 446 ispulled back to retract the loading member 438, the loading member 438compresses a loading spring 450 within the interior working space in thehandle portion 404. When the knob member 446 has been pulled fully backto a retracted position at the end of the longitudinal portion of theslot track 448, the knob member may be translated in a transversedirection into a side portion 452 of the slot track 448 to lock the knobmember 446 and the loading member 438 in a retracted position heldsecurely in place by the force exerted by the compressed loading spring450, thereby also maintaining the snare loop of the snare member 418 inthe retracted position of the securement configuration. As the alignmentmember 420 is also connected to the loading member 438, as the loadingmember 438 is retracted, the alignment member 420 is also retracted withat least a portion of the alignment member being pulled into theinterior working space of the carrier member 406, and includingretracting into the interior working space a bend portion of thealignment member 420 that will make it easier for the alignment member422 disengage from the implant device 200 during an implantationprocedure after the implant device 200 has been released from securementto the carrier member 406. The alignment member may be made for exampleof a shape memory material, such as a nitinol material (nickel-titaniumalloy), with shape memory for the bend portion. The snare member 418 mayalso be made of such a shape memory material with shape memory for thesnare loop.

FIGS. 26-28 more particularly illustrate the process of mounting theimplant device 200 on the mounting portion 408 of the carrier member406. FIG. 26 shows the implantation tool 400 in the loadingconfiguration ready to receive the implant device 200 for mounting. FIG.27 shows sliding the implant device 200 over the alignment member 420toward the snare loop of the snare member 418. FIG. 28 shows the implantdevice 200 fully advanced over the alignment member 420 into animplantation orientation for mounting on the mounting portion 408 of thecarrier member 406. With the implant device 200 in the position as shownin FIG. 28, the knob member may be retracted along the longitudinalportion of the slot track 448 to retract the snare loop of the snaremember 418 around a location on the distal end portion of the implantdevice 200 in the securement configuration. Preferably, the snare loopsecures the implant device 200 to the carrier member at a securementlocation along the distal end portion of the implant device 200 thatcorresponds with a recess area 212 between anchor ridges 210, andpreferably corresponds with the recess area 212 between the most distalpair of adjacent anchor ridges 210 (between which the side ports 250 arepositioned in the example implant device 200). After the snare loop 418is fully retracted around the implant device 200 to securely hold theimplant device 200 to the carrier member 406, the knob member may betranslated to the side into the side portion 452 of the slot track 448to lock the snare member 418 in the securement configuration. With theimplant device 200 secured to the carrier member in an implantationorientation, the carrier member 406 and the implant device 200 securedthereto may be advanced into a surgical path during an implantationprocedure until the implant device 200 is advanced to an implantationposition, preferably with the head 202 of the implant device 200engaging tissue in the lacrimal apparatus in the orbit adjacent aproximal end of the surgical path. Once the implant device 200 is fullyadvanced to the implantation position, then the snare loop of the snaremember 418 may be released to the released configuration forimplantation of the implant device 200.

To reconfigure the snare member 418 from the securement configuration tothe released configuration to release the implant device 200 fromsecurement to the carrier member 406, the release member 410 may beretracted along a translation path within the interior working space ofthe implantation tool 400 by a medical professional pulling back on theend piece 416 to retract the release pin 412 and the release member 410connected to the release pin 412, and to disengage the distal endportion of the release member 410 from the loop end 440 of the snaremember 418. As the loop end 440 of the snare member 418 is released, theloop end 440 is no longer secured in the interior working space withinthe carrier member 406 and the snare loop is released, releasing theimplant device 200 from securement to the carrier member 406, andpermitting the implantation tool 400, and accordingly the carrier member406 to be withdrawn from a surgical path relative to the implant device200 to leave the implant device 200 implanted in an implantationposition through the surgical path to fluidly connect the lacrimalapparatus in the orbit with a paranasal sinus.

The implantation tool 400 includes a lock member 454 that is normallymaintained in a raised position as shown in FIGS. 19, 21 and 22 by alock spring 456. In the raised position, the lock member 454 engages therelease pin 412 to maintain the release pin 412 in a locked position toprevent premature retraction of the release pin 412 and the releasemember 410. Prior to pulling back on the end piece 416 to retract therelease pin 412, the medical professional would depress the lock member454 to unlock the release pin 412, and while holding the lock member 454in the depressed position would pull back on the end piece 416 toretract the release pin 412 and the release member 410. The releasespring 414 may initially be in an uncharged state or, preferably, in acharged extension state with the release spring 414 biasing the releasepin 412 and the release member 410 toward the proximal end 417 of theimplantation tool 400 and urging the end piece 416 toward the releasepin 412, such that when a medical professional pulls back on the endpiece 416, the medical professional must pull with sufficient force toovercome the biasing force of the release spring 414. As may beappreciated, in the configuration shown for the implantation tool 400the release spring 414 and the loading spring 450 will be isolated fromeach other. In alternative configurations to the configuration of theimplantation tool 400 illustrated in

FIGS. 19-28, an implantation tool with a snare-type securement structureof the type illustrated in FIGS. 19-28 may be adapted for mounting animplant device with the carrier member extending through the internalpassage of the implant device and with a snare loop extending around atleast circumferential portion of the exterior of the implant device, forexample including alignment of snare exit apertures such as apertures432 and 434 with features such as side ports 250 of the implant device200.

Implementation Combinations

Some other contemplated embodiments of implementation combinations forvarious aspects of this disclosure, with or without additional featuresas disclosed above or elsewhere herein, are summarized in the exemplarycombinations presented below:

1. An implantation tool to implant a paranasal sinus fluid accessimplant device with an internal fluid communication passage through anartificial, surgical path between a lacrimal apparatus in the orbit anda paranasal sinus in an implantation procedure to provide direct fluidcommunication access through the internal passage from the lacrimalapparatus in the orbit to the paranasal sinus, the implantation toolcomprising:

a carrier member configured to carry the implant device on a mountingportion of the carrier member in a mounted orientation to position theimplant device in an implantation position through the surgical pathfrom an approach through the palpebral fissure during the implantationprocedure;

a securement mechanism to secure the implant device in the implantationorientation on the carrier member to carry the implant device to theimplantation position during the implantation procedure, the securementmechanism being reconfigurable from a securement configuration to securethe implant device to the mounting portion of the carrier member in theimplantation orientation to a released configuration to release theimplant device from securement to the carrier member to permitwithdrawal of the carrier member relative to the implant device to leavethe implant device implanted in the implantation position during theimplantation procedure;

a handle portion connected with the carrier member and configured toremain outside of the surgical path during the implantation procedureand being manipulable by a medical practitioner to direct implantationof the implant device during the implantation procedure;

internal working space housed within at least a portion of the handleportion and at least a portion of the carrier member;

a release mechanism disposed at least in part in the internal workingspace and manipulable to reconfigure the securement mechanism from thesecurement configuration to the released configuration.

2. The implantation tool according to example combination 1, wherein thesecurement mechanism comprises at least one securement member positionedto extend over and press against an exterior portion of the implantdevice in the implantation orientation when the securement mechanism isin the securement configuration.

3. The implantation tool according to example combination 2, wherein thesecurement mechanism comprises at least two said securement members eachpositioned to extend over and press against a said exterior portion ofthe implant device when the securement mechanism is in the securementconfiguration.

4. The implantation tool according to either one of example combination2 or example combination 3, wherein at least one said securement memberextends from outside of to inside of the internal working space in thecarrier member.

5. The implantation tool according to either one of example combination2 or example combination 3, wherein at least one of said securementmember extending distal to a distal end of the mounting portion of thecarrier member in the securement configuration to cover a distal endportion of the implant device when mounted on the mounting portion inthe implantation orientation.

6. The implantation tool according to example combination 5, comprisingat least two said securement members each extends distal to a distal endof the mounting portion of the carrier member in the securementconfiguration, to cover a distal end portion of the implant device whenmounted on the mounting portion in the implantation orientation.

7. The implantation tool according to any one of example combinations2-6, wherein each said securement member is in tension in the securementconfiguration.

8. The implantation tool according to any one of example combinations2-7, comprising a slidable member disposed at least in part in theinternal working space in the carrier member, and the securementmechanism comprises a retainment structure on the slidable member toengage and retain a distal portion of at least one said securementmember in the securement configuration.

9. The implantation tool according to example combination 8, comprisingat least two said securement members, and wherein: the slidable membercomprises at least two said retainment structures, each to engage andretain a said distal portion of a different said securement member inthe securement configuration.

10, The implantation tool according to either one of example combination8 or example combination 9, wherein the slidable member is in a firstposition when the securement mechanism is in the securementconfiguration and is in a second position when the securement mechanismis in the released configuration.

11. The implantation tool according to example combination 10, whereinthe second position is slidably retracted toward a proximal end of theimplantation tool relative to the first position.

12. The implantation tool according to either one of example combination10 or example combination 11, wherein the release mechanism comprises atranslation path within the internal working space in which at least aproximal portion of the slidable member is slidable when slidablyrepositioning the slidable member from the first position to the secondposition.

13. The implantation tool according to either one of example combination11 or example combination 12, wherein the release mechanism comprises aspring mechanism in a charged state applying a biasing force to theslidable member when the slidable member is in at least one of the firstposition and the second position.

14, The implantation tool according to example combination 13, whereinthe spring mechanism is in the charged state when the slidable member isin the first position with the biasing force directed to urging theslidable member toward the second position.

15. The implantation tool according to example combination 14, whereinthe release mechanism comprises an actuator mechanism retained in alocked configuration maintaining the spring mechanism in the chargedstate with the slidable member in the first position, and wherein:

the actuator mechanism is hand manipulable to release the actuatormechanism from the locked configuration to release the spring mechanismfrom the charged state to propel the slidable member to the secondposition.

16. The implantation tool according to example combination 15, whereinthe charged state is a compressed state, and the release of the actuatormechanism from the locked configuration permits expansion of the springfrom the compressed state.

17. The implantation tool according to either one of example combination15 or example combination 16, wherein the actuator mechanism comprises amovable actuation member that is hand movable to release the actuatormechanism from the locked configuration, and the implantation toolcomprises a safety cover selectively movable to selectively cover anduncover the movable actuation member to permit and prevent hand accessto the movable actuation member.

18. The implantation tool according to example combination 17, whereinthe movable actuator member is a depressable member.

19. The implantation tool according to example combination 13, whereinthe spring mechanism is in a charged state when the slidable member isin the first position with the biasing force directed to urging theslidable member toward the first position.

20. The implantation tool according to example combination 19, whereinrelease mechanism comprises and actuator mechanism that ishand-manipulable to apply a force to the spring mechanism to overcomethe biasing force of the spring mechanism and move the slidable memberto the second position against the biasing force.

21. The implantation tool according to example combination 20, whereinthe charged state is an extended state and when the slidable member isin the second position the spring mechanism is in a more extended statethan in the first position.

22. The implantation tool according to any one of example combinations8-21, wherein the slidable member has a lumen therethrough configuredfor passage therethrough of a guide wire to guide a distal end of theimplantation tool to the surgical path during an implantation procedure.

23. The implantation tool according to any one of example combinations8-22, wherein a said retainment structure and a distal portion of asecurement member engaged with a said retainment structure in thesecurement configuration are disposed distal of a distal end of themounting portion of the carrier member, and optionally distal of adistal end of the implant device in the implantation orientation whenthe securement mechanism is in the securement configuration.

24. The implantation tool according to example combination 23, whereineach said retainment structure and each said distal portion of asecurement member engaged with a said retainment structure in thesecurement configuration are disposed distal of a distal end of themounting portion of the carrier member.

25. The implantation tool according to example combination any one ofexample combinations 8-24, wherein a said retainment structure and asaid distal portion of a said securement member engaged with a saidretainment structure in the securement configuration are disposed distalof a distal end of the internal working space in the carrier member.

26. The implantation tool according to example combination 25, whereineach said retainment structure and each said distal portion of asecurement member engaged with a said retainment structure in thesecurement configuration are disposed distal of a distal end of theinternal working space in the carrier member.

27. The implantation tool according to any one of example combinations2-26, wherein at least one said securement member is configured toextend from inside the interior passage of a said implant device mountedin the implantation orientation on the implant portion of the carriermember, through a side port of the said implant device to outside of thesaid implant device, from the side port over a said exterior portion ofthe implant device to a distal end of the implant device and distal tothe distal end of the said implant device.

28. The implantation tool according to example combination 27, whereinat least two said securement members are each configured to extend frominside the interior passage of a said implant device mounted in theimplantation orientation on the implant portion of the carrier member,through a different said side port of the said implant device to outsideof the said implant device, from the said side port over a said exteriorportion of the implant device to a said distal end of the implant deviceand distal to the said distal end of the said implant device.

29. The implantation tool according to either one of example combination27 or example combination 28, wherein each said securement memberconfigured to extend through a said side port has a maximumcross-dimension in a range of from 0.55 millimeter to 0.85 millimeter.

30. The implantation tool according to any one of example combinations2-23, wherein a said securement member comprises a snare member retainedin a snare loop to press against an exterior portion of a portion of asaid implant device received through the snare loop when the securementmechanism is in the securement configuration.

31. The implantation tool according to example combination 30, whereinthe snare member is released from the snare loop when the securementmechanism is in the released configuration.

32. The implantation tool according to any one of example combinations2-29, wherein at least one said securement member comprises a sheathmember configured to extend over a distal end of the implant device inthe implantation orientation when the securement mechanism is in thesecurement configuration; and

the sheath member is configured to cover a radial portion of acircumference around the distal end of the implant device in theimplantation orientation when the securement mechanism is in thesecurement configuration, and optionally the radial portion is at least20°.

33. The implantation tool according to example combination 32, whereinat least two said securement members each comprises a said sheathmember, with each said sheath member configured to extend over adifferent said radial portion of the distal end of the implant devicewhen the securement mechanism is in the securement configuration; and

optionally, each said radial portion is at least 30°.

34. The implant tool according to either one of example combination 32or example combination 33, wherein each said radial portion is notlarger than 120°.

35. The implantation tool according to any one of example combinations2-34, wherein each said securement member is configured to contact asaid exterior portion of a said implant device positioned in theimplantation orientation relative to the mounting portion of the carriermember not more than 5 millimeters proximal of a distal end of theimplant device in the implantation orientation when the securementmechanism is in the securement configuration.

36. The implantation tool according to any one of example combinations1-35, wherein the mounting portion of the carrier member is configuredwith a length along the carrier member between a proximal end and adistal end of the carrier member, wherein a distal end of the mountingportion corresponds with a mounted positioning of a distal end of a saidimplant device in the implantation orientation in the securementconfiguration and a proximal end of the mounting portion correspondswith a mounted positioning of a proximal end of the said implant devicein the implantation orientation in the securement configuration.

37. The implantation tool according to example combinations 1-36,wherein the length of the mounting portion of the carrier member is in arange of from 8 millimeters to 45 millimeters. Optionally the range mayhave a lower limit of 8 millimeters, 10 millimeters, 12 millimeters or15 millimeters and an upper limit of 45 millimeters, 35 millimeters, 30millimeters or 25 millimeters.

38. The implantation tool according to any one of example combinations1-37, comprising an internal passage extending through the implantationtool from the handle portion to adjacent a distal end of theimplantation tool for passing a guide wire through the implantation toolto distal of the distal end of the implantation tool, to guide thedistal end of the carrier member to the surgical path during theimplantation procedure.

39. The implantation tool according to example combination 38, whereinthe internal passage extending through the implantation tool comprises acentral lumen through the implantation tool.

40. The implantation tool according to any one of example combinations1-39, wherein the carrier member has a cross-section at a proximal endof the mounting portion with a maximum cross-dimension of the crosssection in a range of from 0.7 to 1.2 millimeters; and optionally thecarrier has a constant cross-section with the maximum cross-dimensionfor at least 5 millimeters along a length of the mounting portion fromthe proximal end of the mounting portion and further optionally alongthe entire length of the mounting portion.

42. The implantation tool according to example combination 40, whereinthe carrier member has the cross-section for at least 5 millimetersalong the length of the carrier member proximal of the mounting portion

43. The implantation tool according to any one of example combinations1-42, comprising the snare member of either one of example combination30 or example combination 31, and wherein in the securementconfiguration the snare loop in the retracted position has a maximumcross-dimension across the snare loop in a range of from 0.5 millimeterto 1.5 millimeters, and optionally with the range having a lower limitof 0.5 millimeter, 0.6 millimeter or 0.7 millimeter and an upper limitof 1.5 millimeters, 1.3 millimeter or 1.1 millimeter.

44. The implantation tool according to any one of example combinations30, 31 and 43, wherein:

the handle portion is manipulable to reposition the snare member betweena loading configuration and the securement configuration; and

in the loading configuration the snare loop is in an expanded positionto receive the implant device prior to retracting the snare loop to theretracted position to secure the implant device relative to the mountingportion of the carrier member.

45. The implantation tool according to example combination 44, whereinin the loading configuration the snare loop in the expanded position hasa maximum cross-dimension across the snare loop in a range of from 1millimeter to 5 millimeters larger than the maximum cross-dimension inthe retracted position, and optionally the range having a lower limit of1 millimeter, 1.5 millimeters or 2 millimeters and an upper limit of 5millimeters, 4 millimeters or 3.5 millimeters.

46. The implantation tool according to either one of example combination44 or example combination 45 comprising an alignment member, whereinwhen the snare member is in the loading configuration with the snareloop in the expanded position:

the alignment member is disposed through the snare loop and isconfigured to be inserted through the internal passage of the implantdevice to guide the implant device into a loading position to be securedto the exterior of the carrier member in the implantation orientationwhen the snare member is repositioned from the loading configuration tothe securement configuration; and

the alignment member has a free insertion end to be inserted into aproximal end of the internal passage to guide the implant device to theloading position, the free insertion end being disposed along theexterior of carrier member proximal of the snare loop.

47. The implantation tool according to example combination 46, whereinwhen the snare member is in the loading configuration with the snareloop in the expanded position, the implantation tool includes aninsertion stop to limit a distance of insertion travel of the alignmentmember through the internal passage and locate the distal end of theimplant device for the loading position.

48. The implantation tool according to any one of example combinations44-47, comprising: the internal working space extending through at leasta portion of the handle portion and the carrier member in a longitudinaldirection from the proximal end toward the distal end of theimplantation tool; and

a retractor manipulable through the handle portion to selectivelyreconfigure the snare loop from the loading configuration to thesecurement configuration, wherein the retractor comprises a retractionmember disposed in the internal working space and connected with thesnare member, the retraction member being selectively retractable withinthe internal working space toward the proximal end of the implantationtool through manipulation of the handle portion to retract a portion ofthe snare member connected with the retraction member duringreconfiguration of the snare member from the loading configuration tothe securement configuration.

49. The implantation tool according to Example combination 48, whereinthe retractor comprises a spring with at least a portion disposed in theinternal working space proximal the retraction member and positioned inthe internal working space to be compressed when the retraction memberis retracted toward the proximal end of the implantation tool duringreconfiguration of the snare member from the loading configuration tothe securement configuration.

50. The implantation tool according to example combination 49, whereinthe handle portion comprises:

a housing portion with a slot track, the slot track having alongitudinal portion extending in a longitudinal direction along thehandle portion and a side portion extending transverse to thelongitudinal portion; and

a hand-manipulable actuation projection connected with the retractionmember and projecting from the slot track to outside of the housingportion, the actuation projection being slidable along the longitudinalportion of the slot track to retract the retraction member from aforward position disposed toward the distal end of the implant devicewhen the snare member is in the loading configuration to a retractedposition disposed toward the proximal end of the implant device relativeto the forward position, and at the retracted position the actuationprojection being translatable in a transverse direction into the sideportion of the slot track to lock the retraction member in place biasedforward by the compressed spring to retain the snare member locked inthe securement configuration.

51. The implantation tool according to example combination 50, whereinthe longitudinal portion of the slot track has a length in a directionof a longitudinal axis of the implantation tool in a range of from 10millimeters to 15 millimeters.

52. The implantation tool according to any one of example combinations49-52, comprising the alignment member of either one of examplecombination 46 or example combination 47, and wherein the alignmentmember is connected with the retraction member and at least a portion ofthe alignment member is retracted into the internal working space withinthe carrier member when the retraction member is retracted duringreconfiguration of the snare member from the loading configuration tothe securement configuration.

53. The implantation tool according to example combination 52, whereinas the snare member is reconfigured from the loading configuration tothe securement configuration, the alignment member is retracted to beentirely disposed within the internal working space.

54. The implantation tool according to either one of example combination52 or example combination 53, wherein when the snare member is in theloading configuration the alignment member extends from inside theinternal working space to outside of the carrier member through a sideaperture of the carrier member.

55. The implantation tool according to any one of example combinations43-54, comprising a loop release member extending through at least aportion of the internal working space in the carrier member, the looprelease member being slidable within the internal working space betweena first position engaged with an engagement portion of the snare memberto maintain the snare member including a said snare loop and a secondposition disengaged from the engagement portion of the snare member torelease the snare member from including a said snare loop; and wherein:

the release member is in the first position when the snare member is inthe securement configuration and the release member is in the secondposition when the snare member is in the released configuration.

56. The implantation tool according to example combination 55, whereinthe release member is connected with a release handle exposed on thehandle portion of the implantation tool for hand-manipulation adjacent aproximal end of the implantation tool, wherein the release handle ismanipulable to slide the release member in the internal working spacefrom the first position to the second position to release the snare loopand reconfigure the snare member from the securement configuration tothe released configuration.

57. The implantation tool according to example combination 56,comprising a release member spring biasing the release member into thefirst position when the snare member is in the securement position andwherein: manipulation of the release handle to slide the release memberfrom the first position to the second position counteracts a biasingforce of the release spring.

58. The implantation tool according to any one of example combinations55-57, wherein: the handle portion is manipulable to reposition thesnare member between the loading configuration and the securementconfiguration according to any one of example combinations 44-54; and

the release member is retained in the first position when the snaremember is in the loading configuration and while the snare member isreconfigured from the loading configuration to the securementconfiguration.

59. The implantation tool according to any one of example combinations55-58, comprising a release lock manipulable through the handle portionbetween a locked configuration in which the release member is locked inthe first position and an unlocked configuration in which the releasemember is unlocked and movable from the first position to the secondposition.

60. The implantation tool according to any one of example combinations55-59, wherein the handle portion is manipulable to reposition the snaremember between the loading configuration and the securementconfiguration according to any one of example combinations 44-54, andthe implantation tool comprises the alignment member of either one ofexample combination 46 or example combination 47, and wherein thealignment member is connected with the release member and at least aportion of the alignment member is retracted into the internal workingspace within the carrier member when the release member is repositionedfrom the first position to the second position during reconfiguration ofthe snare member from the securement configuration to the releasedconfiguration.

61. The implantation tool according to example combination 60, whereinas the snare member is reconfigured from the securement configuration tothe released configuration, the alignment member is retracted to beentirely disposed within the internal working space.

62. The implantation tool according to either one of example combination60 or example combination 61, wherein when the snare member is in theloading configuration and when the snare member is in the securementconfiguration the alignment member extends from inside the internalworking space to outside of the carrier member through a side apertureof the carrier member.

63. The implantation tool according to any one of example combinations43-62, wherein the snare member has a cross-dimension along all of thesnare member in a said snare loop in a range of from 0.05 millimeters to0.5 millimeters.

64. The implantation tool according to any one of example combinations43-63, comprising the alignment member according to any one of examplecombinations 46, 47, 52, 53 and 60-62, wherein the alignment member isconstructed of a material selected from the group consisting of nitinol,stainless steel, nylon, polyester, PVDF (polyvinylidene fluoride),polypropylene, and polyethylene.

65. The implantation tool according to any one of example combinations43-64, wherein the snare loop in the retracted position is configured toretain the implant device to the exterior of the carrier member in theabsence of the carrier member being disposed through the internalpassage of the implant device.

66. The implantation tool according to example combination 65, whereinthe handle portion is manipulable to reposition the snare member betweena loading configuration and the securement configuration according toany one of example combinations 44-54; and

the snare loop in the expanded position is configured to receive forinsertion therethrough a distal portion of the implant device in theabsence of the carrier member being disposed through the internalpassage of the implant device.

67. The implantation tool according to any one of example combinations1-66, wherein the carrier member has a length in a range of from 10millimeters to 45 millimeters.

68. The implantation tool according to any one of example combinations1-67, wherein the carrier member has a maximum cross-dimension in arange of from 0.7 millimeter to 1.2 millimeters proximal of the mountingportion of the carrier member, and optionally proximal of a distal endof the mounting portion.

69. The implantation tool according to any one of example combinations1-68, wherein the implantation tool has a length in a range of from 100millimeters to 150 millimeters.

70. An implantation assembly for implanting a paranasal sinus fluidaccess implant device through a surgical path between a lacrimalapparatus in the orbit and a paranasal sinus in an implantationprocedure to provide direct fluid communication access from the lacrimalapparatus in the orbit to the paranasal sinus through an internalpassage of the implant device, the implantation assembly comprising:

the implant device: and

the implantation tool according to any one of example combinations 1-69,wherein the implant device is mounted in the mounting orientation on themounting portion of the carrier member with the securement mechanism inthe securement configuration.

71. The implantation assembly according to example combination 70,wherein the implant device is in the absence of the carrier member beingdisposed through the internal passage of the implant device.

72. The implantation assembly according to either one of examplecombination 70 or example combination 71, wherein the internal passageof the implant device is collapsed at a location of securement to themounting portion of the carrier member by the securement mechanism.

73. The implantation assembly according to example combination 70,wherein the carrier member is disposed through the implant device.

74. The implantation assembly according to any one of examplecombinations 70-73, wherein a portion of the implant device in contactwith the securement mechanism comprises a polymeric material ofconstruction having a Shore A durometer in a range of from 50 to 100.

75. The implantation assembly according to example combination 74,wherein the implant device is constructed of polymeric material having aShore A durometer in a range of from 50 to 100.

76. The implantation assembly according to any one of examplecombinations 70-75, wherein the securement mechanism secures the implantdevice to the carrier member at securement locations, and wherein noneof the securement locations are disposed more than 5 millimetersproximal of a distal end of the implant device along the length of thecarrier member.

77. The implantation assembly according to any one of examplecombinations 70-76, wherein the securement mechanism does not contact asaid exterior of the implant device at any location on the implantdevice disposed more than 5 millimeters from a distal end of the implantdevice.

78. The implantation assembly according to any one of examplecombinations 70-77, wherein:

the implant device comprises an exterior anchor surface feature toanchor the implant device in tissue between the lacrimal apparatus inthe orbit and the paranasal sinus, the exterior anchor surface featurecomprising anchor protrusions configured to engage the tissue and recessareas between the anchor protrusions with anchor protrusions andrecesses between anchor protrusions; and the securement mechanismcontacts a said exterior of the implant device extending over at leastone anchor protrusion.

79. The implantation assembly according to any one of examplecombinations 70-78, wherein:

the implant device has a length between a proximal end of the implantdevice and a distal end of the implant device; and

the implant device includes an insertion portion configured to enter andbe advanced by at least some distance through the surgical path duringan implantation procedure, the insertion portion having a length portionin from the distal end along a length of the implant device toward theproximal end that is shorter than a length of the implant device.

80. An implantation kit for implanting a paranasal sinus fluid accessimplant device through a surgical path between a lacrimal apparatus inthe orbit and a paranasal sinus in an implantation procedure to providedirect fluid communication access from the lacrimal apparatus in theorbit to the paranasal sinus through an internal passage of the implantdevice, the implantation kit comprising:

the implantation tool according to any one of example combinations 1-69;and the implant device;

wherein, the implantation tool and implant device are assembled orassemblable into the implantation assembly of any one of examplecombinations 70-79.

81. An implantation kit according to example combination 80, comprisinga fluid treatment formulation contained in a fluid container, the fluidtreatment formulation comprising at least fluid composition foradministration to the paranasal sinus through the internal passage ofthe implant device following implantation to fluidly connect thelacrimal apparatus in the orbit with the paranasal sinus.

An implantation kit according to example combination 81, wherein thefluid treatment formulation comprises at least one drug for treatment ofsinusitis.

83. An implantation kit according to example combination 82, wherein thefluid treatment formulation is an irrigation fluid to irrigate theparanasal sinus.

84. An implantation kit according to any one of example combinations80-83, wherein the implantation assembly is according to examplecombination 79.

85. A method for implanting a paranasal sinus access implant device tofluidly connect a lacrimal apparatus in the orbit with a paranasalsinus, comprising:

with a surgical approach through the palpebral fissure, surgicallyforming an artificial surgical path between a location in a lacrimalapparatus in the orbit and a paranasal sinus;

advancing the implantation assembly of any one of example combinations70-79 from an approach through the palpebral fissure until the implantdevice extends through the surgical path in the implantation position;

manipulating the release mechanism to reconfigure the securementmechanism from the securement configuration to the releasedconfiguration;

withdrawing the implantation tool from the surgical path, leaving theimplant device implanted through the surgical path fluidly connectingthe lacrimal apparatus in the orbit with the paranasal sinus.

86. The method according to example combination 85, comprising after thewithdrawing, administering a fluid treatment formulation to theparanasal sinus through the internal passage of the implanted implantdevice.

87. The method according to either one of example combination 85 orexample combination 86, wherein the implantation assembly is accordingto example combination 79.

88. A method for implanting a paranasal sinus fluid access implantdevice through an artificial, surgical path between a lacrimal apparatusin the orbit and a paranasal sinus to provide direct fluid communicationaccess from the lacrimal apparatus in the orbit to the paranasal sinusthrough an internal passage of the implant device, the methodcomprising:

with the implant device secured to an exterior of a carrier member of animplantation tool with a distal end of the implant device disposedtoward a distal end of the implantation tool and a proximal end of theimplant device disposed toward a proximal end of the implantation tooland with an implantation approach from the lacrimal apparatus in theorbit, advancing the implant device through the surgical path betweenthe lacrimal apparatus in an orbit and the paranasal sinus until theimplant device is in an implantation position with the distal end of theimplant device disposed in the paranasal sinus and the proximal end ofthe implant device disposed in the lacrimal apparatus in the orbit;

after the advancing, releasing the implant device from securement to theexterior of the carrier member and withdrawing the carrier member fromthe surgical path to leave the implant device implanted in theimplantation position fluidly connecting the lacrimal apparatus in theorbit with the paranasal sinus through the internal passage of theimplant device; and

the implant device having a length from the proximal end to the distalend of the implant device; wherein during the advancing a length portionof the implant device, which is smaller than the length of the implantdevice, enters into and advances at least some distance through thesurgical path, and a majority of the length portion is in tension whileadvancing through the surgical path.

89. The method according to example combination 88, wherein theimplantation tool is according to any one of example combinations 1-69and the releasing the implant device comprises manipulating the releasemechanism to reconfigure the securement mechanism from the securementconfiguration to the released configuration.

90. The method according to either one of example combination 88 orexample combination 89, wherein during the advancing, the implant deviceand the implantation tool are in an implantation assembly according toany one of example combinations 70-79.

91. The method, implantation assembly or kit according to any one ofexample combinations 79, 84 and 87-90, wherein the length portion is ina range of from 8 millimeters to 40 millimeters.

92. The method, implantation assembly or kit according to any one ofexample combinations 79, 84, and 87-91, wherein the length of theimplant device is in a range of from 10 millimeters to 45 millimeters.

93. The method, implantation assembly or kit according to any one ofexample combinations 79, 84, 87 and 87-92, wherein the length of theimplant device is up to 2 millimeters longer than the length portion.

94. The method, implantation assembly or kit according to any one ofexample combinations 79, 84, 87 and 87-93, wherein the length of theimplant device is at least 0.15 millimeters larger than the lengthportion.

95. The method, implantation assembly or kit according to any one ofexample combinations 79, 84, 87 and 87-94, wherein the length of theimplant device and the length portion are each at least 12 millimeters.

96. The method, implantation assembly or kit according to any one ofexample combinations 79, 84, 87 and 87-95, wherein the length of theimplant device and the length portion are each at least 15 millimeters.

97. The method, implantation assembly or kit according to any one ofexample combinations 79, 84, 87 and 87-96, wherein the length of theimplant device and the length portion are each no larger than 30millimeters.

98. The method, implantation assembly or kit according to any one ofexample combinations 79, 84, 87 and 87-97, wherein the implant device issecured to the carrier member by securement members that extend over anexterior of the implant device only on a distal portion of the implantdevice within a length distance of less than 50% (one-half) of thelength portion along the length of the implant device from the distalend of the implant device, and optionally less than 30%, less than 25%,less than 20% or less than 15% of the length portion along the length ofthe implant device from the distal end of the implant device, andfurther optionally at least 5% of the length portion along the length ofthe implant device from the distal end of the implant device.

99. The method, implantation assembly or kit according to examplecombination 98, wherein the length distance is not larger than one-thirdof the length portion from the distal end of the implant device.

100. The method, implantation assembly or kit according to either one ofexample combination 98 or example combination 99, wherein the lengthdistance is not larger than 5 millimeters from the distal end of theimplant device, and optionally is not larger than 4 millimeters, notlarger than 3 millimeters or not larger than 2.5 millimeters from thedistal end of the implant device, and further optionally is at least 0.5millimeter or at least 1 millimeter from the distal end of the implantdevice.

101. The method, implantation assembly or kit according to any one ofexample combination 98-100, wherein the length distance is not greaterthan 3 millimeters from the distal end of the implant device.

102. The implantation tool, implantation assembly, kit or methodaccording to any one of example combinations 1-101, wherein theimplantation tool comprises the securement mechanism according to any ofexample combinations 2-35 and one or more said securement members isintegral with the carrier member.

103. The implantation tool, implantation assembly, kit or methodaccording to example combination 102, wherein the implantation toolcomprises a sheath member as recited in any one of example combinations32-34 and the sheath member is integral with the carrier member.

104. The implantation tool, implantation assembly, kit or methodaccording to any one of example combinations 1-103, wherein theimplantation tool comprises a securement member according to any one ofexample combinations 2-35 comprising a material of construction selectedfrom the group consisting of a polyimides, a polyamides (e.g., a nylon),a Mylar, a PET (polyethylene terephthalate), a FEP (fluorinated ethylenepropylene, a PTFE (polytetrafluoroethylene), a nitinol suture material,a PVF (polyvinyl fluorides), a composite polymer and a siliconecomposite composition.

105. The implantation tool, implantation assembly, kit or methodaccording to any one of example combinations 1-103, wherein theimplantation tool comprises a securement member according to any one ofexample combinations 2-35 comprising a polyether block amide elastomeras a material of construction.

The foregoing description of the present invention and various aspectsthereof has been presented for purposes of illustration and description.Furthermore, the description is not intended to limit the invention tothe form disclosed herein. Consequently, variations and modificationscommensurate with the above teachings, and skill and knowledge of therelevant art, are within the scope of the present invention. Theembodiments described hereinabove are further intended to explain knownmodes of practicing the invention and to enable others skilled in theart to utilize the invention in such or other embodiments and withvarious modifications required by the particular application(s) oruse(s) of the present invention. It is intended that the appended claimsbe construed to include alternative embodiments to the extent permittedby the prior art.

The description of a feature or features in a particular combination donot exclude the inclusion of an additional feature or features in avariation of the particular combination. Processing steps and sequencingare for illustration only, and such illustrations do not excludeinclusion of other steps or other sequencing of steps to an extent notnecessarily incompatible. Additional steps may be included between anyillustrated processing steps or before or after any illustratedprocessing step to an extent not necessarily incompatible.

The terms “comprising”, “containing”, “including” and “having”, andgrammatical variations of those terms, are intended to be inclusive andnonlimiting in that the use of such terms indicates the presence of astated condition or feature, but not to the exclusion of the presencealso of any other condition or feature. The use of the terms“comprising”, “containing”, “including” and “having”, and grammaticalvariations of those terms in referring to the presence of one or morecomponents, subcomponents or materials, also include and is intended todisclose the more specific embodiments in which the term “comprising”,“containing”, “including” or “having” (or the variation of such term) asthe case may be, is replaced by any of the narrower terms “consistingessentially of” or “consisting of” or “consisting of only” (or anyappropriate grammatical variation of such narrower terms). For example,a statement that something “comprises” a stated element or elements isalso intended to include and disclose the more specific narrowerembodiments of the thing “consisting essentially of” the stated elementor elements, and the thing “consisting of” the stated element orelements. Examples of various features have been provided for purposesof illustration, and the terms “example”, “for example” and the likeindicate illustrative examples that are not limiting and are not to beconstrued or interpreted as limiting a feature or features to anyparticular example The term “at least” followed by a number (e.g., “atleast one”) means that number or more than that number. The term at “atleast a portion” means all or a portion that is less than all. The term“at least a part” means all or a part that is less than all.

1. An implantation tool to implant a paranasal sinus fluid accessimplant device with an internal fluid communication passage through anartificial, surgical path between a lacrimal apparatus in the orbit anda paranasal sinus in an implantation procedure to provide direct fluidcommunication access through the internal passage from the lacrimalapparatus in the orbit to the paranasal sinus, the implantation toolcomprising: a carrier member configured to carry the implant device on amounting portion of the carrier member in a mounted orientation toposition the implant device in an implantation position through thesurgical path from an approach through the palpebral fissure during theimplantation procedure; a securement mechanism to secure the implantdevice in the implantation orientation on the carrier member to carrythe implant device to the implantation position during the implantationprocedure, the securement mechanism being reconfigurable from asecurement configuration to secure the implant device to the mountingportion of the carrier member in the implantation orientation to areleased configuration to release the implant device from securement tothe carrier member to permit withdrawal of the carrier member relativeto the implant device to leave the implant device implanted in theimplantation position during the implantation procedure; a handleportion connected with the carrier member and configured to remainoutside of the surgical path during the implantation procedure and beingmanipulable by a medical practitioner to direct implantation of theimplant device during the implantation procedure; internal working spacehoused within at least a portion of the handle portion and at least aportion of the carrier member; a release mechanism disposed at least inpart in the internal working space and manipulable to reconfigure thesecurement mechanism from the securement configuration to the releasedconfiguration.
 2. The implantation tool according to claim 1, whereinthe securement mechanism comprises at least one securement memberpositioned to extend over and press against an exterior portion of theimplant device in the implantation orientation when the securementmechanism is in the securement configuration.
 3. The implantation toolaccording to claim 2, wherein the securement mechanism comprises atleast two said securement members each positioned to extend over andpress against a said exterior portion of the implant device when thesecurement mechanism is in the securement configuration.
 4. Theimplantation tool according to claim 2, wherein at least one of saidsecurement member extends distal to a distal end of the mounting portionof the carrier member in the securement configuration to cover a distalend portion of the implant device when mounted on the mounting portionin the implantation orientation.
 5. The implantation tool according toclaim 4, comprising at least two said securement members each extendingdistal to a distal end of the mounting portion of the carrier member inthe securement configuration, to cover a distal end portion of theimplant device when mounted on the mounting portion in the implantationorientation.
 6. The implantation tool according to claim 2, wherein eachsaid securement member is in tension in the securement configuration. 7.The implantation tool according to claim 2, comprising a slidable memberdisposed at least in part in the internal working space in the carriermember, and the securement mechanism comprises a retainment structure onthe slidable member to engage and retain a distal portion of at leastone said securement member in the securement configuration.
 8. Theimplantation tool according to claim 7, comprising at least two saidsecurement members, and wherein: the slidable member comprises at leasttwo said retainment structures, each to engage and retain a said distalportion of a different said securement member in the securementconfiguration.
 9. The implantation tool according to claim 8, whereinthe slidable member is in a first position when the securement mechanismis in the securement configuration and is in a second position when thesecurement mechanism is in the released configuration.
 10. Theimplantation tool according to claim 9, wherein the second position isslidably retracted toward a proximal end of the implantation toolrelative to the first position.
 11. The implantation tool according toclaim 10, wherein the release mechanism comprises a translation pathwithin the internal working space in which at least a proximal portionof the slidable member is slidable when slidably repositioning theslidable member from the first position to the second position.
 12. Theimplantation tool according to claim 11, wherein the release mechanismcomprises a spring mechanism in a charged state applying a biasing forceto the slidable member when the slidable member is in at least one ofthe first position and the second position.
 13. The implantation toolaccording to claim 12, wherein the spring mechanism is in the chargedstate when the slidable member is in the first position with the biasingforce directed to urging the slidable member toward the second position.14. The implantation tool according to claim 13, wherein the releasemechanism comprises an actuator mechanism retained in a lockedconfiguration maintaining the spring mechanism in the charged state withthe slidable member in the first position, and wherein: the actuatormechanism is hand manipulable to release the actuator mechanism from thelocked configuration to release the spring mechanism from the chargedstate to propel the slidable member to the second position.
 15. Theimplantation tool according to claim 14, wherein the charged state is acompressed state, and the release of the actuator mechanism from thelocked configuration permits expansion of the spring from the compressedstate.
 16. The implantation tool according to claim 14, wherein theactuator mechanism comprises a movable actuation member that is handmovable to release the actuator mechanism from the locked configuration,and the implantation tool comprises a safety cover selectively movableto selectively cover and uncover the movable actuation member to permitand prevent hand access to the movable actuation member.
 17. Theimplantation tool according to claim 16, wherein the movable actuatormember is a depressable member.
 18. The implantation tool according toclaim 7, wherein the slidable member has a lumen therethrough configuredfor passage therethrough of a guide wire to guide a distal end of theimplantation tool to the surgical path during an implantation procedure.19. The implantation tool according to claim 7, wherein a saidretainment structure and a said distal portion of a said securementmember engaged with a said retainment structure in the securementconfiguration are disposed distal of a distal end of the internalworking space in the carrier member.
 20. The implantation tool accordingto claim 19, wherein each said retainment structure and each said distalportion of a securement member engaged with a said retainment structurein the securement configuration are disposed distal of a distal end ofthe internal working space in the carrier member.
 21. The implantationtool according to claim 2, wherein at least one said securement memberis configured to extend from inside the interior passage of a saidimplant device mounted in the implantation orientation on the implantportion of the carrier member, through a side port of the said implantdevice to outside of the said implant device, from the side port over asaid exterior portion of the implant device to a distal end of theimplant device and distal to the distal end of the said implant device.22. The implantation tool according to claim 21, wherein at least twosaid securement members are each configured to extend from inside theinterior passage of a said implant device mounted in the implantationorientation on the implant portion of the carrier member, through adifferent said side port of the said implant device to outside of thesaid implant device, from the said side port over a said exteriorportion of the implant device to a said distal end of the implant deviceand distal to the said distal end of the said implant device.
 23. Theimplantation tool according to claim 22, wherein each said securementmember configured to extend through a said side port has a maximumcross-dimension in a range of from 0.55 millimeter to 0.85 millimeter.24. The implantation tool according to claim 2, wherein a saidsecurement member comprises a snare member retained in a snare loop topress against an exterior portion of a portion of a said implant devicereceived through the snare loop when the securement mechanism is in thesecurement configuration.
 25. The implantation tool according to claim24, wherein the snare member is released from the snare loop when thesecurement mechanism is in the released configuration.
 26. Theimplantation tool according to claim 2, wherein at least one saidsecurement member comprises a sheath member configured to extend over adistal end of the implant device in the implantation orientation whenthe securement mechanism is in the securement configuration; and thesheath member is configured to cover a radial portion of a circumferencearound the distal end of the implant device in the implantationorientation when the securement mechanism is in the securementconfiguration.
 27. The implantation tool according to claim 1, whereinthe length of the mounting portion of the carrier member is in a rangeof from 8 millimeters to 45 millimeters.
 28. The implantation toolaccording to claim 27, wherein the carrier member has a cross-section ata proximal end of the mounting portion with a maximum cross-dimension ofthe cross section in a range of from 0.7 to 1.2 millimeters.
 29. Theimplantation tool according to claim 28, wherein the implantation toolhas a length in a range of from 100 millimeters to 150 millimeters. 30.An implantation assembly for implanting a paranasal sinus fluid accessimplant device through a surgical path between a lacrimal apparatus inthe orbit and a paranasal sinus in an implantation procedure to providedirect fluid communication access from the lacrimal apparatus in theorbit to the paranasal sinus through an internal passage of the implantdevice, the implantation assembly comprising: the implant device: andthe implantation tool according to claim 2, wherein the implant deviceis mounted in the mounting orientation on the mounting portion of thecarrier member with the securement mechanism in the securementconfiguration.
 31. The implantation assembly according to claim 30,wherein the implant device is in the absence of the carrier member beingdisposed through the internal passage of the implant device.
 32. Theimplantation assembly according to claim 31, wherein the internalpassage of the implant device is collapsed at a location of securementto the mounting portion of the carrier member by the securementmechanism.
 33. The implantation assembly according to claim 30, whereinthe securement mechanism secures the implant device to the carriermember at securement locations, and wherein none of the securementlocations are disposed more than 5 millimeters proximal of a distal endof the implant device along the length of the carrier member.
 34. Theimplantation assembly according to claim 33, wherein the securementmechanism does not contact a said exterior of the implant device at anylocation on the implant device disposed more than 5 millimeters from adistal end of the implant device.
 35. The implantation assemblyaccording to claim 33, wherein: the implant device comprises an exterioranchor surface feature to anchor the implant device in tissue betweenthe lacrimal apparatus in the orbit and the paranasal sinus, theexterior anchor surface feature comprising anchor protrusions configuredto engage the tissue and recess areas between the anchor protrusionswith anchor protrusions and recesses between anchor protrusions; and thesecurement mechanism contacts a said exterior of the implant deviceextending over at least one anchor protrusion.
 36. A method forimplanting a paranasal sinus fluid access implant device through anartificial, surgical path between a lacrimal apparatus in the orbit anda paranasal sinus to provide direct fluid communication access from thelacrimal apparatus in the orbit to the paranasal sinus through aninternal passage of the implant device, the method comprising: with theimplant device secured to an exterior of a carrier member of animplantation tool with a distal end of the implant device disposedtoward a distal end of the implantation tool and a proximal end of theimplant device disposed toward a proximal end of the implantation tooland with an implantation approach from the lacrimal apparatus in theorbit, advancing the implant device through the surgical path betweenthe lacrimal apparatus in an orbit and the paranasal sinus until theimplant device is in an implantation position with the distal end of theimplant device disposed in the paranasal sinus and the proximal end ofthe implant device disposed in the lacrimal apparatus in the orbit;after the advancing, releasing the implant device from securement to theexterior of the carrier member and withdrawing the carrier member fromthe surgical path to leave the implant device implanted in theimplantation position fluidly connecting the lacrimal apparatus in theorbit with the paranasal sinus through the internal passage of theimplant device; and the implant device having a length from the proximalend to the distal end of the implant device; wherein during theadvancing a length portion of the implant device, which is smaller thanthe length of the implant device, enters into and advances at least somedistance through the surgical path, and a majority of the length portionis in tension while advancing through the surgical path.
 37. A methodfor implanting a paranasal sinus fluid access implant device through anartificial, surgical path between a lacrimal apparatus in the orbit anda paranasal sinus to provide direct fluid communication access from thelacrimal apparatus in the orbit to the paranasal sinus through aninternal passage of the implant device, the method comprising: with theimplant device secured to an exterior of a carrier member of animplantation tool with a distal end of the implant device disposedtoward a distal end of the implantation tool and a proximal end of theimplant device disposed toward a proximal end of the implantation tooland with an implantation approach from the lacrimal apparatus in theorbit, advancing the implant device through the surgical path betweenthe lacrimal apparatus in an orbit and the paranasal sinus until theimplant device is in an implantation position with the distal end of theimplant device disposed in the paranasal sinus and the proximal end ofthe implant device disposed in the lacrimal apparatus in the orbit;after the advancing, releasing the implant device from securement to theexterior of the carrier member and withdrawing the carrier member fromthe surgical path to leave the implant device implanted in theimplantation position fluidly connecting the lacrimal apparatus in theorbit with the paranasal sinus through the internal passage of theimplant device; and the implant device having a length from the proximalend to the distal end of the implant device; wherein during theadvancing a length portion of the implant device, which is smaller thanthe length of the implant device, enters into and advances at least somedistance through the surgical path, and a majority of the length portionis in tension while advancing through the surgical path; and wherein theimplantation tool is according to claim 1 and the releasing the implantdevice comprises manipulating the release mechanism to reconfigure thesecurement mechanism from the securement configuration to the releasedconfiguration.